NCT03061656

Tandem High Dose Chemotherapy With 131I-MIBG Treatment in High Risk Neuroblastoma

High-dose 131I-MIBG Treatment Incorporated Into Tandem High-dose Chemotherapy and Autologous Stem Cell Transplantation in Patients With High-risk Neuroblastoma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Samsung Medical Center · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and toxicity of tandem HDCT/ASCT including high-dose 131I-metaiodobenzylguanidine (MIBG) treatment. In the present study, a single arm trial of tandem HDCT/ASCT will be carried out.

Detailed description

Although the outcome of high-risk neuroblastoma has improved after the introduction of HDCT/ASCT, the outcome was still unsatisfactory with 30-40% of survival. We previously reported the results of a single arm prospective trial (SMC NB-2004 study) using tandem HDCT/auto-SCT for high-risk neuroblastoma. In the NB-2004 trial, total body irradiation (TBI) was incorporated in second transplantation. Survival rates were very encouraging; however, short- and long-term toxicities associated with tandem HDCT/auto-SCT, particularly TBI, were also very significant. For this reason, we designed a new prospective trial (SMC NB-2009 study), in which only TBI in the second HDCT/auto-SCT of NB-2004 study was substituted with high-dose 131I-MIBG treatment in order to reduce short- and long-term toxicities without jeopardizing survival rate.

Conditions

• High Risk Neuroblastoma

Interventions

Type	Name	Description
DRUG	Cyclophosphamide	1st HDCT
DRUG	Carboplatin	1st HDCT
DRUG	Etoposide	1st HDCT
RADIATION	131I-MIBG	2nd HDCT
DRUG	Thiotepa	2nd HDCT
DRUG	Melphalan	2nd HDCT

Timeline

• Start date: 2009-01-01
• Primary completion: 2013-12-31
• Completion: 2018-12-31
• First posted: 2017-02-23
• Last updated: 2018-09-18